A method and device for reduction or treatment of deep vein thrombosis (DVT) are described in international patent application WO2006/054118. A method and device for reducing peripheral vascular resistance in the blood circulation of a patient are described in international patent application WO2010/070332. WO2006/054118 and WO2010/070332 are incorporated herein by reference.
WO2006/054118 relates to a device for reduction or treatment of DVT in a patient. The device is designed to be placed directly against the skin of the patient. Consequently, the electrodes of the device would not be able to penetrate through the hair of a non-human mammal to make contact with the skin. Additionally, the electrodes are not designed to engage and grip the hair and skin of a non-human mammal. Therefore, the device of WO2006/054118 is not suitable for the treatment of neuromuscular stimulation of one or more muscles, or muscle groups of a non-human mammal such as a horse.
WO2010/070332 relates to a device for preventing diastolic flow reversal in a patient. The device is designed to be placed directly against the skin of the patient. Consequently, the electrodes of the device would not be able to penetrate through the hair of a non-human mammal to make contact with the skin. Additionally, the electrodes are not designed to engage and grip the hair and skin of a non-human mammal. Therefore, the device of WO2010/070332 is not suitable for the treatment of neuromuscular stimulation of one or more muscles, or muscle groups of a non-human mammal such as a horse.
U.S. Pat. No. 6,615,080 relates to a neuromuscular electrical stimulation (NMES) device for the prevention of DVT by stimulating the musculature on the sole of the foot of a patient. The electrodes of the device, when in use, are designed to push through the material of a sock worn by a patient and consequently make contact with the skin of the patient. The electrodes are not designed to engage and grip hair of a non-human mammal. Consequently, the device would not be suitable for the treatment of neuromuscular stimulation of one or more muscles, or muscle groups of a non-human mammal such as a horse.
WO01/003768 relates to a transcutaneous electro neuro or muscular stimulation unit. The electrodes of the device are designed to be placed directly against the skin of a patient. WO99/64105 relates to a portable adjustable stimulator for preventing DVT. The electrodes of the device are designed to be placed directly against the skin of a patient and are held against the skin of the patient by a cuff or sleeve. GB 2 404 858 relates to a DVT and circulation therapy device. The electrodes of the device when in use are designed to be placed directly against the skin of the patient. US 2010/0076533 relates to a device for transmitting an electrical stimulation to a bodily tissue of a patient. The electrodes of the device when in use are designed to be placed directly against the skin of the patient. U.S. Pat. No. 5,487,759 relates to an electrical nerve and muscle stimulation and associated support device. The electrodes of the device when in use are designed to be placed directly against the skin of the patient. The electrodes of the devices of WO99/64105, GB 2 404 858, US 2010/0076533 and U.S. Pat. No. 5,487,759 would not be able to penetrate through the hair of a non-human mammal to make contact with the skin. Additionally, the electrodes are not designed to engage and grip the hair and skin of a non-human mammal. Consequently, the devices would not be suitable for the treatment of neuromuscular stimulation of one or more muscles, or muscle groups of a non-human mammal such as a horse.
GB 2 454 481 relates to a dressing with an integral electrical stimulation unit. The apparatus is designed to be placed directly against the skin of a patient for the treatment of tissue damage such as a laceration or incision. GB 2 422 549 relates to flexible electrodes comprising a honey-comb mesh designed to be placed directly against the skin for the stimulation of wound healing. The electrodes of the devices of GB 2 454 481 and GB 2 422 549 would not be able to penetrate through the hair of a non-human mammal to make contact with the skin. Additionally, the electrodes are not designed to engage and grip the hair and skin of a non-human mammal. Consequently, the device would not be suitable for the treatment of neuromuscular stimulation of one or more muscles, or muscle groups of a non-human mammal such as a horse.
The equine hoof, on contact with the ground during locomotion, dissipates the energy of impact by compression of the frog and the underlying digital cushion, and by distortion of the hoof especially at the heels. In turn, the venous plexus at the heels is compressed resulting in displacement of blood from the hoof and augmentation of perfusion within the limb. Consequently, vascular perfusion of the equine limb is enhanced by exercise and locomotion, but is reduced by restriction of locomotion and confinement. Similarly, horses that are confined to a stable frequently develop distal limb oedema, most commonly affecting the hind limbs, through relative stasis of interstitial fluid and lymphatic drainage. Under circumstances in which horses require prolonged periods of confinement due to ailments and maladies, due to the requirement for isolation, or for other reasons that result in restricted activity, these factors may have a deleterious impact on the health, welfare or performance of the horse. In particular, this will be true in clinical situations in which tissue perfusion and interstitial fluid drainage are already compromised, the requirement for ‘box confinement’ exacerbating this compromise with detrimental consequences for the individual.
Compromise of the flow of blood and interstitial fluid affect the rate of healing of superficial injuries and lesions in deeper structures by limiting tissue oxygenation and the transfer of cells, solutes and metabolites. This may influence the recovery from disease affecting a variety of structures including skin, muscles, tendons, ligaments and joints. In addition, in situations in which the flux of blood and interstitial fluid is compromised, delivery of veterinary pharmaceutical products and other medicinal agents from blood to tissues may be sub-optimal or inadequate. Furthermore, in horses exhibiting oedema, discomfort may be experienced, together with a reduced inclination for locomotion, resulting in further exacerbation of compromised fluid flux within tissues. These factors may have deleterious repercussions for the recovery of horses from injuries or diseases irrespective of whether confinement is a feature of their management.
It is believed that the method and device as described herein for augmenting fluid flux in and around tissues by neuromuscular stimulation will have wide ranging benefits to horses suffering clinical disease through promotion of tissue oxygenation, cell, solute and metabolite transfer, heat distribution and distribution of medicinal products. In particular, the health and welfare of horses exhibiting oedema through stasis of interstitial fluid, impaired lymphatic drainage or other mechanisms will be improved.
It is further believed that the method and device as described herein will provide beneficial effects in horses with compromised cardiovascular output due to a number of different pathological or physiological states that result in sub-optimal tissue perfusion. In particular, the compromised cardiovascular output may result from disease or physiological states involving the heart and vasculature, or other organs and systems that have an influence on cardiac output or blood flow. In addition, it may result from postural affects e.g. associated with recumbence during general anaesthesia, or it may result from the influence of medicinal products e.g. agents used for general anaesthesia.
It is further believed that the method and device as described herein will provide benefits to performance horses that are free from clinical disease. Such horses include racehorses, and horses involved in competitions at professional or amateur levels including but not limited to dressage, cross-country, show jumping, endurance and all types of harness and carriage events. These benefits can be elicited by application of the method and device to horses in transit and confined to stables prior to competition, and to horses following exertion in training or competition. In the former scenario, the flux of fluid in and around tissues will be enhanced despite restriction of locomotion, thereby limiting the physiological and metabolic consequences of confinement that otherwise might exist. In the latter scenario, augmentation of tissue perfusion and fluid flux will aid recovery of muscles from the physiological and metabolic effects of exertion. In particular, it is believed that the method and device will limit the development of delayed onset muscle soreness (DOMS) that typically occurs in the days following exertion, this being of particular significance for horses in the late stages of training prior to any competition in which optimal performance is required. Although paucity of information exists for DOMS in all species and conjecture exists regarding its mechanism of onset, including in man, it is accepted to occur in all species used for athletic activities, such as racing, and can be alleviated by neuromuscular stimulation using the method and device.
In summary, it is believed that the method and device described herein will provide benefits to horses subjected to restriction of locomotion, horses that have sustained diseases or injuries that may or may not be complicated by infection, inflammation and oedema, horses with generalised oedema due to systemic disease, and in horses with compromised general, regional or local blood flow. In addition, irrespective of the existence of concurrent disease or pathological processes, it is believed that the method and device will aid the distribution to tissues of medicinal products administered by systemic route, it will counter the adverse effect on tissue perfusion associated with certain postures, it will counter the adverse effect on tissue perfusion associated with certain medicinal products, and it will enhance competitive performance and aid recovery from exertion in horses.
It should be emphasised that the method and device, although described herein for the benefit of horses, could be used on non-human mammals of other species due to similarities in anatomy, physiology and pathology that exist between the non-human mammalian species such as a dog, cat, goat, sheep, horse and a cow.